Watson settles with Endo, Teikoku Seiyaku over generic version of Lidoderm patch

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

Watson announced Tuesday a settlement through one of its subsidiaries with Endo Pharmaceuticals and Teikoku Seiyaku Co. over its generic version of Lidoderm (lidocaine) topical patch. Lidoderm had sales of $1.2 billion during the 12-month period ended in March 2012, according to IMS Health.

Under the agreement, Watson can launch its version of the patch in September 2013, as long as it's approved by the Food and Drug Administration. Endo will receive 25% of the gross profit from Watson's sales of the patch during the 180 days of market exclusivity that it expects to receive as the first company to file for FDA approval. The agreement also will allow Watson to distribute up to $96 million worth of branded Lidoderm during the first eight months of 2013; if it doesn't receive FDA approval for the generic by Jan. 1, 2014, then it will be allowed to distribute an additional $80 million worth of the branded version for the rest of the year and, if it doesn't receive approval by Jan. 1, 2015, it can distribute another $64 million worth for nine months.


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.

Comments

I hope that this gets

I hope that this gets straightened out soon. Resources like http://www.rxwiki.com/lidoderm say that lidoderm is used for people with pain from years of shingles. Many doctors prescribe it for off-label uses. Hopefully, an affordable version will be available soon.